Equidone Oral Gel

Name: Equidone Oral Gel

EQUIDONE® Gel (domperidone)

CAUTION

Federal law (USA) restricts this drug to use by or on the order of a licensed veterinarian.

For oral use in horses only.

Indications

For prevention of fescue toxicosis in periparturient mares.

Contraindication

Horses with hypersensitivity to domperidone should not receive EQUIDONE Gel.

Information for horse owners

Owners should be aware that treatment with EQUIDONE Gel may result in failure of passive transfer of immunoglobulins to the foal and that this may occur even when the mare does not drip milk. Owners should be advised that all foals born to mares treated with EQUIDONE Gel should be tested for serum immunoglobulin (IgG) concentrations. Owners should be informed that EQUIDONE Gel causes false positives on the milk calcium test used to predict foaling. Owners should be directed on the proper use of the multi-dose dosing syringe, including how to set the dial ring for accurate dosing after the first dose.

Equidone Oral Gel - Clinical Pharmacology

Domperidone is a D2 dopamine receptor antagonist that blocks the agonistic action of fescue alkaloids at the cellular level. Unlike other D2 antagonist drugs, domperidone does not readily cross the blood-brain barrier4. Distribution studies with radio-labeled drug in animals have shown wide tissue distribution, but low brain concentration. Small amounts of the drug cross the placenta in rats5. In humans, domperidone is 91-93% bound to plasma proteins. Domperidone in humans undergoes rapid and extensive hepatic metabolism by hydroxylation and N-dealkylation1. Urinary and fecal excretions of domperidone in humans amount 31 and 66% of the oral dose, respectively. The proportion of the drug excreted unchanged in humans is small (10% of fecal excretion and approximately 1% of urinary excretion). The average terminal plasma half-life of domperidone administered orally to horses is approximately 6 hours with very low systemic bioavailability.

PRINCIPAL DISPLAY PANEL - 25 mL Syringe Carton

NADA 141-314
Approved by FDA

EQUIDONE® Gel
(domperidone)

D2 dopamine receptor antagonist
for oral use in horses only.

EQUIDONE Gel is indicated for
prevention of fescue toxicosis in
periparturient mares.

CAUTION: Federal law (USA)
restricts this drug to use by or
on the order of a licensed
veterinarian.

NDC: 17033-326-06

Dechra

EQUIDONE 
domperidone gel
Product Information
Product Type PRESCRIPTION ANIMAL DRUG Item Code (Source) NDC:17033-326
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
domperidone (domperidone) domperidone 110 mg  in 1 mL
Product Characteristics
Color WHITE (Off white opaque) Score     
Shape Size
Flavor APPLE Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:17033-326-06 6 SYRINGE, PLASTIC (SYRINGE) in 1 CARTON
1 25 mL in 1 SYRINGE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NADA NADA141314 09/09/2010
Labeler - Dechra Veterinary Products (362142734)
Establishment
Name Address ID/FEI Operations
Accupac Inc. 071609663 MANUFACTURE
Revised: 08/2010   Dechra Veterinary Products
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